Most ankle sprain research is either false or clinically unimportant: A 30-year audit of Randomized Controlled Trials

C M Bleakley, Mark Matthews, James Smoliga

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Abstract

Lateral ankle sprain (LAS) is the most common musculoskeletal injury. Although clinical research in this field is growing, there is a broader concern that clinical trial outcomes are often false and fail to translate into patient benefits. The aim of this review was to audit 30 years of experimental research related to LAS management (n=74 RCT) and to determine if reports of treatment effectiveness could be validated beyond statistical certainty. Seventy-seven percent of trials reported positive treatment effects but there was a high risk of false discovery. Most trials were unregistered and relied solely on statistical significance, or lack of statistical significance, rather than interpreting key measures of minimum clinical importance (eg. minimal detectable change, minimal clinically important difference). Future clinical trials must adopt higher standards of reporting and data interpretation. This includes consideration of the ethical responsibility to preregister their research; and interpretation of clinical outcomes beyond statistical significance.
Original languageEnglish
JournalJournal of Sport and Health Science
Early online date11 Nov 2020
Publication statusE-pub ahead of print - 11 Nov 2020

Keywords

  • ankle sprain
  • MCID
  • MDC
  • False discovery
  • p-value

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